Medtronic E5540MASKIT Instructions for Use

CD Horizon™ Spinal System M708348B414E Rev. H

2021-07-14

IMPORTANT INFORMATION ON THE CD HORIZON™ SPINAL SYSTEM

PURPOSE

The CD Horizon™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct
to fusion of the thoracic, lumbar, or sacral spine.

DESCRIPTION

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples,
and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked
into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These
constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws,
Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components
can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These
include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only
cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel,
medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non­pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples and
washers, GDLH™ rods, hooks, connectors and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and
Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: certain components
are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters.
Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and
associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD
Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium,
titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™
Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied
warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never

use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory

Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These
staples are not to be used in pediatric patients.

PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK
rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as
interbody fusion devices in the anterior spinal column.

To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system
or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and
neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

INDICATIONS

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an
adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation),
spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt
chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in
skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt
chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD
Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/
spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be
used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage
for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices
are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the
non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to
spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis,
trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction
System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™
indications.

CONTRAINDICATIONS

Contraindications include:

▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Medical or surgical conditions which would preclude the potential benefit of spinal implant surgery such as the presence of

congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count
(WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented metal allergy or intolerance.
▪ Cases not needing a bone graft and fusion.
▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ CD Horizon™ Spire™ plate and CD Horizon™ PEEK rods are specifically contraindicated for use in pediatric patients.
▪ Patients unwilling to follow postoperative instructions.
▪ Cases not described in the indications.

Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

POTENTIAL ADVERSE EVENTS

All adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of
potential adverse events includes:

▪ Early or late loosening of components.
▪ Disassembly, bending, or breakage of components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general corrosion) including

metallosis, staining, tumor formation, or autoimmune disease.

▪ Pressure on skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin

penetration, irritation, fibrosis, necrosis, or pain.

▪ Bursitis.
▪ Tissue or nerve damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
▪ Loss of neurological function (e.g. sensory or motor) including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, or development or continuation of pain, numbness,
neuroma, spasms, sensory loss, tingling sensation, or visual deficits.

▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,

irritation, arachnoiditis, muscle loss.

▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of spinal bone (including the sacrum, pedicles, or vertebral

body) or bone graft or bone graft harvest site at, above, or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, or mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stresses shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction, loss of bowel control, or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound

necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.)
▪ Change in mental status.
▪ Death.

Note: additional surgery may be necessary to correct some of these potential adverse events.

ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS

▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions and/or distorted anatomy).
▪ Pedicle screw malpositioning, with or without neurological or vascular injury.
▪ Proximal or distal junctional kyphosis.
▪ Pancreatitis.

WARNING

Safety and effectiveness of pedicle screw spinal systems were established only for spinal conditions with significant mechanical
instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity
of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurologic
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Safety and
effectiveness of this device for any other conditions are unknown. Implants are not prostheses. In the absence of fusion,
instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to
every day mechanical stresses.

These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. CD Horizon™ PEEK
rods are intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. This device is not a
prosthesis and is not intended for standalone use.

A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices
should also never be resterilized. Reprocessing or reuse may compromise the structural integrity of these implants and create a
risk of contamination of the implants which could result in patient injury, illness, or death.

ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS

Warning: safety and effectiveness of this device was not established for use as part of a growing rod construct. This device is
only intended to be used when definitive fusion is being performed at all instrumented levels.

Use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and
skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the
use of pedicle screws or increase risk of pedicle screw malpositioning and neurological or vascular injury. Patients not skeletally
mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational
spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.

Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in
pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.

ADDITIONAL WARNING FOR THE CD HORIZON™ SPIRE™ SPINOUS PROCESS PLATE

Consider the extent of decompression, as well as the amount of intact bone remaining on the spinous processes, when using
the CD Horizon™ Spire™ plate as the sole supplemental fixation for an interbody fusion procedure.

PRECAUTIONS

Implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in
the use of this pedicle screw spinal system because this is a technically demanding procedure presenting risk of serious injury
to patients.

Successful results are not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise results. This device system is not intended to be the sole means of spinal support.
Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can

withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of devices
will eventually occur.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of implants are important considerations in successful use of the system. Further, proper selection and compliance of
patients greatly affect results. Patients who smoke were shown to have an increased incidence of non-unions. These patients
should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol abuse patients are also poor
candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for
spine fusion.

ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS

Implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with
specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding
procedure presenting risk of serious injury to patients.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of implants are important considerations in successful use of the system in pediatric patients.

Selection of proper size, shape, and design of the implant for patients is crucial to the safe use of this device in pediatric
patients.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.

For US audiences only

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

IMPLANT SELECTION

Selection of proper size, shape, and design of implants for patients is crucial to success of the procedure. Implants are subject
to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human bones.
Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize
stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending, or loosening of devices
before the healing process is complete which may result in further injury or the need to remove the device prematurely.

DEVICE FIXATION

In cases where a percutaneous posterior approach is used, refer to the CD Horizon™ Sextant™ surgical technique. CD
Horizon™ Spinal System instrumentation contains rods and implants of various diameters, which are intended to be used with
device specific instruments. For self-breaking plugs, always hold the assembly with the counter torque device. Tighten and
break-off the head of the plug to leave the assembly at optimum fixation security. After the upper portion of the self-breaking
plug is sheared off, further re-tightening is not necessary and not recommended. The head portion should not remain in the
patient. After the upper portion of the self-breaking plug is sheared off, re-adjustment is not possible unless the plug is removed
and replaced with a new one.

When using DTT Transverse Links, the M6 plug should be tightened between 8 and 9Nm. (70 to 80 inch-lbs). CD Horizon™
PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as
interbody fusion devices in the anterior spinal column.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and pre dispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used when handling and storing implant components. Implants should not be scratched or otherwise

damaged. Implants and instruments should be protected during storage, especially from corrosive environments.

▪ An adequate inventory of implants should be available at the time of surgery; normally a quantity in excess of what is

expected to be used.

▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the

equipment and should personally assemble the devices to verify all parts and necessary instruments are present before
surgery. CD Horizon™ Spinal System components are not to be combined with components from another manufacturer.

▪ Unless sterile packaged, all devices should be sterilized before use. Additional sterile components should be available in

case of an unexpected need.

INTRAOPERATIVE

▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of neurological

functions.

▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to patients or operative personnel.
▪ Rods should not be repeatedly or excessively bent. Rods should not be reverse-bent in the same location. Use great care

to ensure implant surfaces are not scratched or notched since such actions may reduce the functional strength of the
construct. If rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface perpendicular to
the midline of the rod. Cut rods outside the operative field. Whenever possible, use pre-cut rods of the length needed.

▪ Use an imaging system to facilitate surgery.

▪ To insert a screw properly, a guide wire should first be used, followed by a sharp tap. Caution: be careful the guide wire, if

used, is not inserted too deep, becomes bent, and/or breaks. Ensure the guide wire does not advance during tapping or
screw insertion. Remove the guide wire and ensure it is intact. Failure to do so may cause the guide wire or part of it to
advance through the bone and into a location that may cause damage to underlying structures.

▪ Caution: do not over-tap or use a screw/bolt that is either too long or too large. Over-tapping, using an incorrectly sized

screw/bolt, or accidentally advancing the guidewire during tap or screw/bolt insertion may cause nerve damage,
hemorrhage, or the other possible adverse events listed in this document. If screws/bolts are being inserted into spinal
pedicles, use as large a screw/bolt diameter as will fit into each pedicle.

▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper vertebrae to the lower

vertebrae being fused.

▪ To ensure maximum stability, two or more Crosslink™ plates or DTT Transverse Links on two bilaterally placed, continuous

rods should be used whenever possible.

▪ Bone cement should not be used because safety and effectiveness of bone cement is not determined for spinal uses, and

this material will make removal of components difficult or impossible. Heat generated from the curing process may also
cause neurologic damage and bone necrosis.

▪ Before closing soft tissues, provisionally tighten (finger tighten) all nuts or screws, especially screws or nuts that have a

break-off feature. Once this is completed, go back and firmly tighten all screws and nuts. Recheck the tightness of all nuts
or screws after finishing to ensure none loosened during the tightening of other nuts or screws. Failure to do so may cause
loosening of other components.

POSTOPERATIVE

The physician's postoperative directions and warnings to patients, and the corresponding patient compliance, are extremely
important.

▪ Detailed instructions on use and limitations of the device should be given to patients. If partial weight-bearing is

recommended or required prior to firm bony union, patients must be warned that bending, loosening, and/or breakage of
devices are complications which may occur as a result of excessive or early weight-bearing or muscular activity. Risk of
bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased
if patients are active, debilitated, or demented. Patients should be warned to avoid falls or sudden jolts in spinal position.

▪ To allow the maximum chances for a successful surgical result, patients or devices should not be exposed to mechanical

vibrations or shock that may loosen the device construct. Patients should be warned of this possibility and instructed to limit
and restrict physical activities, especially lifting and twisting motions and any type of sport participation. Patients should be
advised not to smoke tobacco, use nicotine products, or consume alcohol or non-steroidals or anti-inflammatory
medications such as aspirin during the bone graft healing process.

▪ Patients should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for this

permanent physical restriction in body motion.

▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on implants. By the

mechanism of fatigue, these stresses can cause the eventual bending, loosening, or breakage of devices. It is important
that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by
roentgenographic examination. If a state of non-union persists or if components loosen, bend, or break, devices should be
revised or removed immediately before serious injury occurs. Patients must be adequately warned of these hazards and
closely supervised to ensure cooperation until bony union is confirmed.

▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic

antibiotics may be considered, especially for high-risk patients.

▪ CD Horizon™ Spinal System implants are temporary internal fixation devices. Internal fixation devices are designed to

stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no functional
purpose and may be removed. While the final decision on implant removal is, of course, up to the surgeon and patient, in
most patients, removal is indicated because implants are not intended to transfer or support forces developed during normal
activities. If deviced are not removed following completion of its intended use, one or more of the following complications
may occur: (1) corrosion, with localized tissue reaction or pain; (2) migration of implant position possibly resulting in injury;
(3) risk of additional injury from postoperative trauma; (4) bending, loosening, and breakage which could make removal
impractical or difficult; (5) pain, discomfort, or abnormal sensations due to the presence of devices; (6) increased risk of
infection; (7) bone loss due to stress shielding; and (8) potential unknown or unexpected long term effects such as
carcinogenesis. Implant removal should be followed by adequate postoperative management to avoid fracture, re-fracture,
or other complications.

▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all

orthopedic implants, CD Horizon™ Spinal System components should never be reused under any circumstances.

VISUAL INSPECTION

Visually inspect all sterile barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not
use the product. Contact Medtronic for return information.

Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return
information.

PACKAGING

Devices may be supplied sterile or non-sterile. Packages for each of the components should be intact upon receipt. Once the
seal on the sterile package is broken, the product should not be re-sterilized. If a loaner or consignment system is used, all sets
should be carefully checked for completeness and all components should be carefully checked to ensure there is no damage
prior to use. Damaged packages or products should not be used and should be returned to Medtronic.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by Medtronic, all implants used in
surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products
should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam-sterilized by
the hospital using one of the sets of process parameters in Table 1.

Table 1: Sterilization cycle parameters for the US and its territories

Method Cycle Temperature Exposure time

Minimum dry time

Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes

Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment. It is the user’s responsibility to use only sterilizers and accessories
(such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) cleared
by the Food and Drug Administration (FDA) for the selected sterilization cycle specifications (time and temperature). Sterilization
cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.

*For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.

Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories

Method Cycle Temperature Exposure time

Minimum dry time

Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes* 30 Minutes

1

1

1

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric

pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
Only sterile products should be placed in the operative field. The general instruments used with this device are provided non-

sterile. Refer to the instrument package insert for sterilization parameters and requirements. No implant should be reused once
it comes into contact with human tissue or body fluid. Always immediately clean and re-sterilize instruments used in surgery.
This process must be performed before handling or (if applicable) returning to Medtronic.

MRI INFORMATION

The CD Horizon™ Spinal System has not been evaluated for safety, heating, migration, or compatibility in the MR environment.
It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the CD Horizon™ Spinal
System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

PRODUCT COMPLAINTS

For product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Do not re-use

Batch code

Manufacturer

Catalogue number

Non-sterile

For US audiences only

This device complies with applicable European Union
regulations and directives.

This device complies with applicable European Union
regulations and directives.

Sterilized using irradiation

Sterilized using ethylene oxide

Use-by date

Consult instructions for use at this website.